Endoscope working channel with multiple functionality

ABSTRACT

Endoscopic instrument assemblies and methods for making and using the same. An example endoscopic instrument assembly includes an endoscope having a working channel and an endoscopic instrument slidably disposed in the working channel. The inside surface of the working channel and the outside surface of the endoscopic instrument each have a non-circular cross-sectional shape along at least a portion of their respective lengths.

FIELD OF THE INVENTION

This invention pertains broadly to surgical instruments. Moreparticularly, this invention pertains to an endoscope and endoscopicinstruments that are disposed in a working channel of the endoscope.

BACKGROUND

A wide variety of medical devices have been developed for medical use,for example, endoscopic and/or surgical use. Some of these devicesinclude endoscopes, endoscopic instruments, and other related devicesthat have certain characteristics. Of the known medical devices, eachhas certain advantages and disadvantages. There is an ongoing need toprovide alternative designs and methods of making and using medicaldevices.

BRIEF SUMMARY

The invention provides design, material, and manufacturing methodalternatives for medical devices, for example, endoscopes, endoscopicinstruments, and endoscopic instrument assemblies. An example endoscopicinstrument assembly includes an endoscope having a working channel andan endoscopic instrument slidably disposed in the working channel. Theinside surface of the working channel and the outside surface of theendoscopic instrument each have a non-circular cross-sectional shapealong at least a portion of their respective lengths. Methods for makingand using medical devices including endoscopic instrument assemblies arealso disclosed. Some of these and other features and characteristics ofthe inventive devices and methods are described in more detail below.

The above summary of some embodiments is not intended to describe eachdisclosed embodiment or every implementation of the present invention.The Figures, and Detailed Description, which follow, more particularlyexemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be more completely understood in consideration of thefollowing detailed description of various embodiments of the inventionin connection with the accompanying drawings, in which:

FIG. 1 is side view of an example endoscopic instrument assembly;

FIG. 2 is a cross-section across line 2-2 in FIG. 1;

FIG. 3 is a cross-sectional view of an example working channel;

FIG. 3A is a cross-section across line 3A-3A in FIG. 3;

FIG. 3B is a cross-section across line 3B-3B in FIG. 3;

FIG. 4 is a side view of a portion of an example endoscopic instrument;

FIG. 4A is a cross-section across line 4A-4A in FIG. 4;

FIG. 4B is a cross-section across line 4B-4B in FIG. 4;

FIG. 5 is a cross-sectional view of another example working channel;

FIG. 6 is a cross-section across line 6-6 in FIG. 5;

FIG. 7 is an alternative example cross-section taken across line 6-6 inFIG. 5;

FIG. 8 is a cross-sectional view of another example working channelhaving a plurality of endoscopic instruments disposed therein; and

FIG. 9 is a cross-sectional view of the working channel shown in FIG. 8having a plurality of different instruments disposed therein.

DETAILED DESCRIPTION

The following description should be read with reference to the drawingswherein like reference numerals indicate like elements throughout theseveral views. The detailed description and drawings illustrate exampleembodiments of the claimed invention.

FIG. 1 illustrates an example endoscopic instrument assembly 10.Assembly 10 includes an endoscope 12 and an endoscopic instrument 14disposed in a working channel (not shown in FIG. 1, see FIG. 2 forexample working channels) defined in endoscope 12. Endoscope 12 includesan elongate tubular portion 18 and a proximal handle portion 20 adaptedto manipulate and direct the distal end of tubular portion 18.

Endoscopic instrument 14 may include an end effector 22 and one or morecontrol members 24 that may manipulate or otherwise control end effector22. In some embodiments, end effector 22 may be a biopsy forceps orlinkage mechanism as depicted in FIG. 1. Alternatively, end effector 22may be a snare loop, scissors, punch, needle, and the like, or any othersuitable device. Control member 24 may include a thumb ring 26 and adisplaceable spool 28, which can be used to manipulate and/or actuateend effector 22. Some additional details regarding suitable types of endeffectors and control members (which can also be described as or takethe form of handles) can be found in U.S. Pat. Nos. 6,537,205;6,840,900; 6,454,702; 6,881,186; 6,235,026; and 6,517,539, the entiredisclosures of which are incorporated herein by reference.

FIG. 2 is a cross-sectional view of tubular portion 18 of endoscope 12.Here it can be seen that tubular portion 18 may include one or morechannels. One or more of these channels, for example channel 30, may beprovided for receiving an optical scope or camera device 32 (which maybe built therein). A number of additional lumens 34/36/38/40 may beincluded for receiving control wires 42/44/46/48 that may extend fromthe handle portion 20 through the tubular portion 18. One or moreworking channels 50/52/54/56 may also be provided for receivingendoscopic instruments, for example endoscopic instrument 14,therethrough. Other lumens 58/60 may be provided for other purposes.Some additional details regarding endoscopes are described in general inU.S. Pat. No. 5,179,935 to Miyagi, which is incorporated herein byreference in its entirety. It should be noted that tubular portion 18could also be a tubular medical device other than an endoscope, such asa catheter or guiding tube that includes any number of the features andcharacteristics of similar devices disclosed herein. Therefore, to theextent applicable, discussion found below relating to channels andinstruments may also be applicable to tubular medical devices such ascatheters or guiding tubes that include one, two, three or more lumensor channels that are configured to accommodate instruments.

Working channel 52, as depicted in FIG. 2, has a non-circularcross-sectional shape. In this example, the cross-sectional shape isthat of a six-sided polygon (i.e., a hexagon). It can be appreciatedthat a number of alternative shapes may be utilized without departingfrom the spirit of the invention. For example, the cross-sectional shapemay resemble a three, four, five, six, seven, eight, nine, ten, or moresided polygon. The polygon may be regular (i.e., all sides having thesame length and all angles between the sides being equal) or irregular.In addition, any other suitable “non-polygonal” shape may be utilizedincluding partially circular shapes, irregular shapes, random shapes,other geometric shapes, or any other suitable shape. Otherconfigurations may include a screw thread or helical ridge or grooveformed in channel 52. It should be noted that a vast variety of shapesare contemplated for working channel 52 as well as other channels andinstruments disclosed herein.

An endoscopic instrument 62 is disposed in channel 52. Instrument 62 hasa generally circular cross-sectional shape. The differences between theshape of channel 52 and instrument 62 may be desirable for a number ofreasons. For example, because of the differences in the shape, the blankor vacant space between channel 52 and instrument 62 may allow forfluids to be infused or aspirated through channel 52 while instrument 62is in place. In some instances, a secondary device (e.g., a needle,guidewire, etc.) may also be disposed in channel 56 adjacent instrument62. The converse of working channel 52 and instrument 62 is workingchannel 56 and endoscopic instrument 64. Here, channel 56 has agenerally circular cross-sectional shape while instrument 64 has anon-circular cross-sectional shape. This arrangement may be desirablefor similar reasons as the arrangement of channel 52 and instrument 62.

In addition, the differences in shape between channels 52/56 andinstruments 62/64 may also reduce the surface area in which channels52/56 and instruments 62/64 are in contact. Reducing surface areacontact or otherwise providing space between the working channel and theendoscopic instrument may reduce “backlash” (also known as “whip”).Backlash is understood to be a phenomenon where rotation or othermanipulations of an instrument (e.g. instruments 62/64) on one end isnot immediately translated to the other end of the instrument until,after a certain amount of un-translated motion occurs, the instrumentabruptly translates the motion and/or otherwise “whips” around to catchup with the motion.

Channel 50 is similar to channel 52 in that it has a non-circularcross-sectional shape. Unlike channel 52, however, is that endoscopicinstrument 14 disposed in channel 50 also has a non-circularcross-sectional shape. The shapes of channel 50 and instrument 14 are,thus, complementary. i.e., the inner surface of working channel 50 hasan inner perimeter and the outer surface of endoscopic instrument 14 hasan outer perimeter, and the inner perimeter and the outer perimeter aresubstantially equal. The complementary shapes allow instrument 14 to fitwithin channel 50 much like how a key fits in a lock.

Utilizing a “lock-and-key” relationship between channel 50 andinstrument 14 may be desirable for a number of reasons. For example,using complementary shapes allows the user to keep track of theorientation of instrument 14 within channel 50. This may be particularlyuseful when the endoscopic intervention depends on instrument 14 havinga particular orientation and/or when it is helpful to the clinician toknow what orientation instrument 14 is in at any given time. Forexample, it may be useful for a clinician to know whether a particularend effector 22 (e.g., a biopsy forceps) is “rightside-up” or“upside-down” prior to attempting to actuate the end effector 22. Tofurther aid this orientation capability, instrument 14 may also includea visual indicia of origin (not shown) such as a colored marker or imagethat indicates the orientation of instrument 14. Of course, a number ofalternative indicia of origin may also be used without departing fromthe spirit of the invention.

Instrument 14′ is disposed in channel 54 and is similar to instrument 14except that the cross-sectional shape of instrument 14′ is defined by asleeve or coating 66 disposed on the outer surface of instrument 14′.Sleeve 66 allows an otherwise round instrument 14′ to utilize thelock-and-key relationship described above and take advantage of itsdesirable properties.

Sleeve 66 may include a number of different materials. For example,sleeve 66 may comprise a polymer such as polytetrafluoroethylene (PTFE),ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene(FEP), polyoxymethylene (POM, for example, DELRIN® available fromDuPont), polyether block ester, polyurethane, polypropylene (PP),polyvinylchloride (PVC), polyether-ester (for example, ARNITEL®available from DSM Engineering Plastics), ether or ester basedcopolymers (for example, butylene/poly(alkylene ether) phthalate and/orother polyester elastomers such as HYTREL® available from DuPont),polyamide (for example, DURETHAN® available from Bayer or CRISTAMID®available from Elf Atochem), elastomeric polyamides, blockpolyamide/ethers, polyether block amide (PEBA, for example availableunder the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA),silicones, polyethylene (PE), Marlex high-density polyethylene, Marlexlow-density polyethylene, linear low density polyethylene (for exampleREXELL®), polyester, polybutylene terephthalate (PBT), polyethyleneterephthalate (PET), polytrimethylene terephthalate, polyethylenenaphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI),polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide(PPO), poly paraphenylene terephthalamide (for example, KEVLAR®),polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMSAmerican Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinylalcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC),polycarbonates, ionomers, biocompatible polymers, other suitablematerials, or mixtures, combinations, copolymers thereof, polymer/metalcomposites, and the like. In some embodiments, lubricious polymers(including those listed above such as polytetrafluoroethylene) maydesirably improve the ability for instrument 14′ to move within channel54. Moreover, because increased lubricity may be desirable, sleeve 66can also be applied to the outer surface of instrument 14 or any otherinstrument having a non-circular cross-sectional shape. Sleeves orlubricious coatings may also be utilized for channels and otherinstruments described herein so that these instruments may more easilymove within these channels.

Endoscopic instrument assembly 10 may be used by disposing tubularportion 18 within a body lumen. For example, for an endoscopic procedurethat accesses the stomach, tubular portion 18 may extend through themouth of a patient, down through the esophagus, and into the stomach.Once positioned, instrument 14 (or any other instrument describedherein) can extend through the appropriate working channel and into thebody lumen. Inside the body lumen, the instrument may be actuated so asto perform its intended intervention.

It is once again useful to consider that a number of differentcross-sectional shapes are contemplated for the various working channelsand endoscopic instruments described herein. For example, a number ofdifferent polygons (e.g., one, two, three, four, five, six, seven,eight, nine, or more sided), partially rounded, irregular, geometric,non-geometric, or other shapes can be used for any of the channels orinstruments without departing from the spirit of the invention. It isworth noting that a cross-sectional shape may be described as an inneror outer diameter, an inner or outer perimeter, or by any other suitabledesignation. To the extent applicable, these descriptions can be usedinterchangeably.

In some embodiments, the non-circular cross-sectional shape of workingchannels 50/52/54 and instruments 14/14′/64 extend the full length ofeach given device. However, this need not be the case. For example, FIG.3 illustrates a cross-section of another example working channel 68 thathas an inner surface 70 with a first region 72 having a non-circularcross-sectional shape and a second region 74 with a generally circularcross-sectional shape. A transverse cross-sectional representation offirst region 72 is depicted in FIG. 3A and a transverse cross-sectionalrepresentation of second region 74 is depicted in FIG. 3B. Analogously,FIG. 4 illustrates a side view of another example endoscopic instrument114 that has an outer surface 76 with a first region 78 having anon-circular cross-sectional shape and a second region 80 with agenerally circular cross-sectional shape. A transverse cross-sectionalrepresentation of first region 78 is depicted in FIG. 4A and atransverse cross-sectional representation of second region 80 isdepicted in FIG. 4B.

Instrument 114 and channel 68 may be used together or with any othersuitable partner. When used together, it can be appreciated that whennon-circular first region 78 of instrument 114 engages non-circularfirst region 72 of channel 68, instrument 114 “keys” channel 68.Conversely, when first region 78 of instrument 114 is disposed adjacentsecond region 74 of channel 68, instrument 114 can be more easilyrotated within channel 68. The combination of these design featuresallows the clinician to take advantage of the desirable properties ofboth circular and non-circular devices by simply shifting thelongitudinal position of instrument 114 relative to channel 68.

Designs like these that utilize a non-circular cross-sectional shapealong only a portion of the length may provide the endoscopic assemblywith a number of desirable features. For example, because a substantialportion of the length of channel 68 and/or instrument 114 have agenerally circular cross-sectional shape, non-circular first regions72/78, when not engaged with one-another, may have reduced surface areacontact with circular second regions 74/80. This relationship can reducebacklash and allow for fluid infusion and/or aspiration. Similarly, whennon-circular first regions 72/78 are engaged with one another, they maydesirably have improved orientation compatibility and otherwise takeadvantage of the desirable benefits of the “lock-and-key” arrangement.

The length, number, position, and shape of first regions 72/78 can varyin a number of different embodiments. For example, non-circular firstregions 72/78 can span any portion of the length of either channel 68 orinstrument 114. Likewise, differing embodiments of channel 68 andinstrument 114 may include one, two, three, four, or more first regions72/78. In addition, the various non-circular first regions 72/78 can bepositioned at essentially any longitudinal position along channel 68 andinstrument 114. For example, FIGS. 3 and 4 illustrate first regions72/78 being positioned away from the ends of channel 68 and instrument114. However, this need not be the case as numerous embodiments arecontemplated that position first regions 72/78 adjacent the proximalend, distal end, or both of channel 68 and instrument 114, respectively.Similarly, the shape of first regions 72/78 can vary to be any usefulshape.

FIG. 5 illustrates another example channel 82 that is similar to otherchannels described herein. Channel 82 includes an inner surface 83having a section 84 with a generally circular cross-sectional shape andanother section 86 having a non-circular cross-sectional shape. Section86 may include a rotatable member 87 that is rotatable within section 84as best seen in FIG. 6. Here it can be seen that rotatable member 87includes a plurality of teeth or gears 88. A control member or rod 90having a gear 92 can be extended through an opening 93 in section 84 andinto engagement with teeth 88. Rod 90 extends proximally to a positionaccessible by the clinician. With gear 92 engaged with teeth 88,rotation of rod 90 rotates rotatable member 87. Thus, rod 90 and gears88 function much like a worm gear and this configuration can be utilizedto rotate section 86 when desired. In some embodiments, a second rod 90a may also be utilized on the opposing side of section 84, and/or amotor may be disposed in or adjacent working channel 82 and be coupledto member 87 for rotating member 87. In alternative embodiments,rotatable member 87 and/or rod 90 may have mating or complementary screwthreads (or a screw thread on one structure and a gear on the other todrive the screw thread) that provide essentially the same features.

Rod 90 may utilize any number of different forms and/or materialcompositions. For example, rod 90 may be made from a metal or metalalloy. Some examples of suitable metals and metal alloys includestainless steel, such as 304V, 304L, and 316LV stainless steel; mildsteel; nickel-titanium alloy such as linear-elastic or super-elasticnitinol, nickel-chromium alloy, nickel-chromium-iron alloy, cobaltalloy, tungsten or tungsten alloys, MP35-N (having a composition ofabout 35% Ni, 35% Co, 20% Cr, 9.75% Mo, a maximum 1% Fe, a maximum 1%Ti, a maximum 0.25% C, a maximum 0.15% Mn, and a maximum 0.15% Si),hastelloy, monel 400, inconel 825, or the like; other Co—Cr alloys;platinum enriched stainless steel; or other suitable material.Alternatively, rod 90 may comprise a polymer, metal-polymer composite,and the like, or any other suitable material.

Section 86 and rotatable member 87 may be desirable for a number ofreasons. For example, a clinician may dispose an endoscopic instrument(such as any of those shown or described herein) through channel 82 andthen need to rotate the instrument. With a non-circular section of theinstrument “keyed” with section 86, a clinician can rotate rod 90 torotate rotatable member 87 and, consequently, the instrument.

Another desirable feature of rotatable member 87 is that because it maybe placed at or near the distal end of channel 82, torque can be applieddirectly at the distal end of the instrument rather than at the proximalend of the instrument. This may result in a more efficient transfer oftorque and it may reduce the incidence of backlash because of the factthat torque is being applied to the instrument at a location that ismuch closer to where torque transmission is desired (e.g., near the endeffector).

FIG. 7 illustrates an alternative section 186 that includes rotatablemember 187 that is rotatable within section 84 of channel 82. One ormore wires 194 are disposed about rotatable member 187, with ends 192a/192 b of wires 194 extending into openings 93 and then extendingproximally to a location accessible by the clinician. Ends 192 a/192 bor wires 194 can be pulled by the clinician in order to rotate section186. For the same reasons set forth above, this may help to efficientlytransmit torque and reduce backlash.

FIG. 8 illustrates another example working channel 96 that is similar inform and function to the other channels described above. A plurality ofinstruments 98 a/98 b are disposed in channel 96. This arrangementdemonstrates that multiple instruments 98 a/98 b, each having anon-circular cross-sectional shape, can be disposed in channel 96. Insome embodiments, instruments 98 a/98 b may have a combined shape thatis complementary to the cross-sectional shape of channel 96. Thecombination of instruments 98 a/98 b, thus, may take advantage of thedesirable features of the “lock-and-key” arrangement described above.Alternatively, a plurality of generally circular instruments 99 a/99 bmay be disposed in channel 96 as shown in FIG. 9. This arrangement maybe desirable by reducing the surface area contract between instruments99 a/99 b and channel 96 as described above. Of course, a combination ofthese arrangements is also contemplated where a non-circular instrument(e.g., instrument 98 a) and a generally circular instrument (e.g.,instrument 99 a) are disposed in channel 96. Regardless of whatarrangement is utilized, any combination of instruments 98 a/98 b/99a/99 b may be used with any suitable channel, including any of thosedescribed herein.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps without exceeding the scope of theinvention. The invention's scope is, of course, defined in the languagein which the appended claims are expressed.

1. An endoscopic instrument assembly, comprising: an endoscope defininga working channel therein; an inner surface defined by the workingchannel, wherein the inner surface has a first portion having asubstantially circular cross-sectional shape, a second portion having asubstantially circular cross-sectional shape, and a rotatable lockportion including an inner perimeter defined by the inner surface andhaving a non-circular cross-sectional shape, the lock portion beingdisposed between the first portion and the second portion, wherein thefirst portion, the lock portion, and the second portion extend in seriesalong a length of the working channel; an endoscopic instrument slidablydisposed in the working channel, the endoscopic instrument having anouter surface with a key portion including an outer perimeter defined bythe outer surface and having a non-circular cross-sectional shape; andwherein the non-circular cross-sectional shape of the inner perimeter issubstantially the same as the non-circular cross-sectional shape of theouter perimeter.
 2. The endoscopic instrument assembly of claim 1,wherein the cross-sectional shape of the lock portion of the workingchannel and the cross-sectional shape of the key portion of theendoscopic instrument are complementary.
 3. The endoscopic instrumentassembly of claim 1, wherein the lock portion of the working channel hasa polygonal cross-sectional shape.
 4. The endoscopic instrument assemblyof claim 1, wherein the key portion of the endoscopic instrument has apolygonal cross-sectional shape.
 5. The endoscopic instrument assemblyof claim 1, further comprising means for rotating the lock portion. 6.The endoscopic instrument assembly of claim 5, wherein means forrotating the lock portion comprises a rod and a gear disposed adjacentthe rod.
 7. The endoscopic instrument assembly of claim 5, wherein meansfor rotating the lock portion includes one or more wires.
 8. Theendoscopic instrument of claim 1, further comprising a second endoscopicinstrument disposed in the working channel, wherein the secondendoscopic instrument has an outer surface with a non-circularcross-sectional shape.
 9. The endoscopic instrument of claim 8, whereinthe outer surface of the endoscopic instrument and the outer surface ofthe second endoscopic instrument define a combined outer surface, andwherein the shape of the combined outer surface is complementary withthe shape of the lock portion of the working channel.
 10. The endoscopicinstrument of claim 1, wherein a cross-sectional area of the key portionis larger than a remaining cross-sectional area of the endoscopicinstrument.
 11. The endoscopic instrument of claim 1, wherein across-sectional area of the lock portion is smaller than across-sectional area of the first portion and a cross-sectional area ofthe second portion.
 12. The endoscopic instrument of claim 1, whereinthe lock portion is disposed between the first portion and the secondportion along a longitudinal axis of the inner surface.
 13. Theendoscopic instrument of claim 6, wherein the rod is disposed in a gapformed on the inner surface.
 14. The endoscopic instrument of claim 6,wherein the gear is integrally formed on an outer surface of the lockportion.
 15. An endoscopic instrument assembly, comprising: an endoscopehaving a working channel formed therein; an inner surface defined by theworking channel, wherein the inner surface has a first portion with asubstantially circular cross-sectional shape, a second portion with asubstantially circular cross-sectional shape, and a rotatable lockportion including an inner perimeter defined by the inner surface andhaving a polygonal cross-sectional shape, wherein the first portion, thelock portion, and the second portion extend in series along a length ofthe working channel; an endoscopic instrument slidably disposed in theworking channel, the endoscopic instrument having an outer surface witha key portion including an outer perimeter defined by the outer surfaceand having a polygonal cross-sectional shape; and wherein the polygonalcross-sectional shape of the inner perimeter is substantially the sameas the polygonal cross-sectional shape of the outer perimeter.
 16. Anendoscopic instrument assembly, comprising: an endoscope having aworking channel formed therein; an inner surface defined by the workingchannel, wherein the inner surface has a first portion having asubstantially circular cross-sectional shape, a second portion having asubstantially circular cross-sectional shape, and a rotatable lockportion including an inner perimeter defined by the inner surface andhaving a non-circular cross-sectional shape, wherein the first portion,the lock portion, and the second portion extend in series along a lengthof the working channel; an endoscopic instrument slidably disposed inthe working channel, the endoscopic instrument having an outer surfacedefining a key portion including an outer perimeter defined by the outersurface and having a non-circular cross-sectional shape; a controlmember disposed adjacent the rotatable lock portion for rotating therotatable lock portion; and wherein the non-circular cross-sectionalshape of the inner perimeter is substantially the same as thenon-circular cross-sectional shape of the outer perimeter.
 17. Theendoscopic instrument assembly of claim 16, wherein the rotatable lockportion includes a plurality of teeth and wherein the control membercomprises a gear engagable with the plurality of teeth.
 18. Theendoscopic instrument assembly of claim 16, wherein the control memberincludes one or more wires disposed about the rotatable lock portion andextending proximally therefrom.
 19. The endoscopic instrument of claim16, wherein the cross-sectional shape of the rotatable lock portion ofthe working channel and the cross-sectional shape of the key portion ofthe endoscopic instrument are complementary.